This was announced by the EEC Minister for Technical Regulation Viktor Nazarenko at the 2nd All-Russian Forum with International Participation “NOVAMED-2022”, which was held in Moscow from 10 to 11 November.
Victor Nazarenko informed the forum participants of all significant changes in the law of the Eurasian Economic Union. He noted that the new edition of the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, which have entered into force this year, provides for the possibility of submitting documents on the tests of medical devices directly by the manufacturer, without recourse to testing laboratories. The document provides in certain cases the possibility of making changes in the registration dossier of medical devices in a notification procedure without expert work on the part of the authorized body. It also optimizes the procedures of accession of new states to the registration of a medical device.
According to the Minister of the EEC, further optimization of the procedure may allow a multiple increase in the volume of registration of medical devices.
“The Unified Register of authorized organizations that have the right to conduct studies of medical devices for the purpose of their registration now includes
32 testing laboratories and 47 medical organizations,” noted Victor Nazarenko. – We need to analyze the problematic issues of testing laboratories and, based on this analysis, prepare proposals for measures to support the activities of testing laboratories and medical organizations (clinical trial bases).”
Victor Nazarenko also noted that a road map for the transition to registration under the law of the Union has been prepared, which is planned to be adopted this year at the meeting of the Council of the Commission. It includes both the activities of the authorized bodies of the countries of the Union and joint activities with the Commission. Among them: analysis of problematic issues of testing laboratories and preparation of proposals for their support measures, preparation of experts and inspectors to work according to the Union rules, provision of stable information influence in the sphere of medical products circulation, optimization of registration procedure of medical products and elimination of double regulation.
“According to the plan, the main part of the activities should be completed by the end of 2023. This will ensure the unconditional transition to registration under the rules of the Union after the end of the transitional period of the agreement in late 2025,” said the EEC minister.
In conclusion, Victor Nazarenko also informed about the start of elaboration of the Concept of further development of the medical devices market stipulated by the Strategic directions of development of the Eurasian economic integration until 2025. He noted the main objectives of the concept taking into account the experience of the market and the need to introduce the best practices of the member states of the Union into the law of the Union, as well as taking into account the response of the common market of the EAEU to global challenges and changes in the current economic environment.
